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FDA Approves Study of New Treatment for Migraine
Article Summary: The FDA has approved a new study to evaluate stimluation of nerves in the back of the neck as a treatment for migraine headache. This approach offers hope to millions of migraine patients who do not respond to current treatments.
The US Food and Drug Administration (FDA) has approved a study in humans of a new treatment for migraine headache. The treatment involves the precise delivery of tiny electrical shocks to the occipital nerve in the back of the neck to mask the perception of pain.
The study, known as PRISM (Precision Implantable Stimulator for Migraine) will use Boston Scientific Corporation’s (NYSE: BSX) Precision Neurostimulator to evaluate the safety and effectiveness of occipital nerve stimulation to treat migraine headache. The study will involve approximately 150 patients at up to 15 sites in the United States.
The treatment offers hope to the millions of migraine sufferers who do not respond to conventional treatment. In the U.S., there are more than 28 millions migraine sufferers. Of these, up to 10 percent may not respond to existing treatments. Existing treatments include a range of medications and therapy.
"Occipital nerve stimulation has the potential to provide relief to the large population of refractory migraine sufferers who currently have no other medical treatments available to them," said Dr. David Biondi, Director of the Headache Management Program at Spaulding Rehabilitation Hospital in Boston and Instructor of Neurology at Harvard Medical School. "If effective, the Precision implantable neurostimulator would provide a new treatment option to free these patients from their long-standing headache pain."
The Precision neurostimulator is the smallest rechargeable neurostimulator on the market today and is already approved by the FDA for spinal cord stimulation to treat chronic pain. The device deliver precisely controlled electrical impulses to the spinal cord which mask the perception of pain. This treatment is prescribed for patients with chronic pain in the limbs, trunk and back. In the new study, the device will be used to stimulate the occipital nerves located just under the skin at the back of the neck.
"As the smallest rechargeable neurostimulator available, our Precision device represents a best-in-class neuromodulation technology that has treated more than 2,000 patients suffering from chronic pain," said Jeffrey H. Greiner, President of Boston Scientific's Neuromodulation Group. "We are excited about the prospect of extending this same advanced technology to address the unmet needs of migraine sufferers."
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Boston Scientific's Neuromodulation Group is a global leader in the development of implantable, high-technology neurostimulation devices that include new treatments for deafness and chronic pain.
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David Altfeder
Hayden Lewis is the owner of http://www.buybutalbital.net , http://www.onlinepharmacyzone.com and http://www.buyfioricet.biz . He has written a series of articles on medicine, pharmacology and the pharmacy industry.
